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Vessel Density in nAMD After Longterm Anti-VEGF Treatment Compared to Recently Started Anti-VEGF Treatment

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ClinicalTrials.gov Identifier: NCT03833830
Recruitment Status : Recruiting
First Posted : February 7, 2019
Last Update Posted : February 7, 2019
Sponsor:
Collaborator:
Cenaug Foundation
Information provided by (Responsible Party):
Dr. med. Katja Hatz, Vista Klinik

Brief Summary:
Neovascular age-related macular degeneration (nAMD) is characterized by the abnormal growth of blood vessels from the choroid into the subretinal space which leads to sub- and intraretinal fluid accumulation, hemorrhages and subretinal fibrosis with progressive loss of central vision. Intravitreal anti-VEGF treatment is the standard of care. Intravitreal anti-VEGF application might temporarily increase intraocular pressure due to a volume effect. It remains unclear if repeated injections might have an impact on retinal capillary perfusion. Therefore this study aims to investigate the vascular microcirculation differences between patients who received longterm intravitreal Anti-VEGF treatment and patients who recently started Anti-VEGF treatment using Optical Coherence tomography Angiography (OCTA).

Condition or disease Intervention/treatment
Neovascular Age-related Macular Degeneration Diagnostic Test: Optical Coherence Tomography angiography (OCTA)

Detailed Description:

Main outcome parameters are:

  • Vessel Perfusion Area (%) of central ETDRS subfields and peripapillar region as evaluated by OCTA (single measurement)
  • Blood flux index(*) of central ETDRS subfields and peripapillar region as evaluated by OCTA (single measurement).
  • Peripapillary and perifoveal retinal nerve fiber layer (RNFL) thickness (µm) as evaluated by OCT (single measurement)
  • Intraocular pressure (IOP) (mmHg) (single measurement at study visit) and mean intraocular pressure during anti-VEGF treatment period (evaluated as mean of all retrospectively available IOP measures from the beginning of treatment, mmHg)

(*)Blood flux index is automatically calculated by ARI Network as the mean flow intensity in the vessel area, where the blood flow signal was normalized to 0 to 1 by dividing by the full dynamic range of blood flow signal intensity.


Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Cross Sectional Study Assessing the Perifoveal and Peripapillar Vessel Density in nAMD After Longterm Anti-VEGF Treatment Compared to Recently Started Anti-VEGF Treatment - Pilotstudy
Actual Study Start Date : January 7, 2019
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Group/Cohort Intervention/treatment
longterm treatment group
previous treatment (before Optical Coherence Tomography angiography (OCTA)) >20 injections
Diagnostic Test: Optical Coherence Tomography angiography (OCTA)
There will be an OCTA measurement (observational study) for both groups. Group allocation will be made due to previous anti-VEGF treatments (longterm treatment group >20 injections and shortterm treatment group < 5 injections).

shortterm treatment group
previous treatment (before Optical Coherence Tomography angiography (OCTA)) < 5 injections
Diagnostic Test: Optical Coherence Tomography angiography (OCTA)
There will be an OCTA measurement (observational study) for both groups. Group allocation will be made due to previous anti-VEGF treatments (longterm treatment group >20 injections and shortterm treatment group < 5 injections).




Primary Outcome Measures :
  1. Vessel Perfusion Area (%) and Flux index* of central ETDRS subfields and peripapillar region (single measurements at study visit), respectively, in both goups [ Time Frame: baseline V0 ]
    in both goups (longterm treatment group ( ≥20 intravitreal injections) and shortterm treatment group (<5 intravitreal injections).


Secondary Outcome Measures :
  1. Peripapillary and perifoveal retinal nerve fiber layer (RNFL) thickness (µm) as evaluated by OCT (single measurement at study visit) [ Time Frame: baseline V0 ]
    in both goups (longterm treatment group ( ≥20 intravitreal injections) and shortterm treatment group (<5 intravitreal injections).

  2. Intraocular pressure (IOP) (mmHg) (single measurement at study visit) and mean intraocular pressure during anti-VEGF treatment period (evaluated as mean of all retrospectively available IOP measures from the beginning of treatment, mmHg) [ Time Frame: baseline V0 ]
    in both goups (longterm treatment group ( ≥20 intravitreal injections) and shortterm treatment group (<5 intravitreal injections).

  3. weight [ Time Frame: baseline V0 ]
    weight messurements in kg

  4. hight [ Time Frame: baseline V0 ]
    hight messurements in cm



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive recruitment. All patients from Vista Klinik attending the retina outpatient clinic, who fulfil the in- and exclusion criteria, will be offered the participation in the study.
Criteria

Inclusion Criteria:

To be eligible for participation, patients will be required to

  • have been treated for sub- or juxtafoveal CNV due to nAMD with anti-VEGF intravitreal injections either for at least 20 times (longterm treatment eyes) or <5 times (shortterm treatment eyes).
  • give written consent to participation

Exclusion Criteria:

  • diagnosis of glaucoma/ocular hypertension at baseline of anti-VEGF treatment

    • history of retinal vascular disorders like diabetic retinopathy, retinal vein/arterial occlusive disease, uveitis etc.
    • history of papillary disease which might interfere with interpretation of peripapillary OCT/OCTA evaluation such as severe tilted disc, parapapillar CNV, papillar drusen, optic nerve neuritis, papillar edema etc.
    • inability to perform OCTA examination of sufficient quality.
    • history of any side effects of Tropicamide eye drops

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03833830


Contacts
Contact: Katja Hatz, MD +41614266079 katja.hatz@vista.ch
Contact: Susanne Müller, Study Coord. +41614266079

Locations
Switzerland
Vista Klinik Recruiting
Binningen, Baselland, Switzerland, 4102
Contact: Katja Hatz, Dr. med.    +41 61 426 60 79    khatz@vistaklinik.ch   
Sponsors and Collaborators
Dr. med. Katja Hatz
Cenaug Foundation
Investigators
Principal Investigator: Katja Hatz, MD Vista Klinik Binningen

Responsible Party: Dr. med. Katja Hatz, Head of medical retina department, Vista Klinik
ClinicalTrials.gov Identifier: NCT03833830     History of Changes
Other Study ID Numbers: OCTA 2018-02043
First Posted: February 7, 2019    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: if necessary on request

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents